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| Name | Class |
|---|---|
| Sutro Biopharma, Inc. | INDUSTRY |
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This is a multi-center, open-label, monotherapy dose escalation, PK bridging, and dose expansion Phase I/IIa study in Chinese adult subjects to evaluate the safety, tolerability, Pharmacokinetics (PK) profiles, immunogenicity, and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors.
This study consists of two parts, Phase I (dose escalation and PK bridging) and Phase IIa (dose expansion). Subjects in each cohort of Phase I will be administered 3 scheduled dose levels of STRO-002 as monotherapy by intravenous infusion until intolerable toxicity, radiographic disease progression, or subject withdrawal for other reasons. 5 dose arms are tentatively set based on the available safety, PK and efficacy data of STRO-002 for the Phase IIa (dose expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1(Phase I) | Experimental | STRO-002 3.5 mg/kg Open Lable |
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| Cohort 2(Phase I) | Experimental | STRO-002 4.3 mg/kg Open Lable |
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| Cohort 3(Phase I) | Experimental | STRO-002 5.2 mg/kg Open Lable |
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| Cohort A(Phase IIa) | Experimental | Recurrent and/or progressive ovarian epithelial cancer, confirmed by immunohistochemistry [IHC] testing with FolRα positive expression (TPS ≥ 75%). |
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| Cohort B(Phase IIa) | Experimental | Recurrent and/or progressive ovarian epithelial cancer, confirmed by IHC testing with FolRα positive expression (25% ≤ TPS < 75%). |
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| Cohort C(Phase IIa) | Experimental | Recurrent and/or progressive endometrial cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STRO-002 | Biological | STRO-002 is an Antibody-drug conjugates (ADCs) combine the specificity of monoclonal antibodies with the anti-tumor activity of cytotoxic drugs. |
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| Measure | Description | Time Frame |
|---|---|---|
| DLT Assessment | Toxicity associated with the treatment of the investigational drug STRO-002. | From Day1 to Day21 after first dose of STRO-002 |
| AE Assessment | The frequency of AE | From first dose of STRO-002 until 28 days after the last dose of STRO-002 |
| AUC | PK parameter：area under the concentration-time curve (AUC) | From first dose of STRO-002 until 28 days after the last dose of STRO-002. |
| Cmax | PK parameter：Cmax | From first dose of STRO-002 until 28 days after the last dose of STRO-002. |
| Half life (t1/2) | PK parameter：half life (t1/2) | From first dose of STRO-002 until 28 days after the last dose of STRO-002. |
| Overall response rate (ORR) | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Determine the recommended phase II dose (RP2D) | From first dose of STRO-002 until 28 days after the last dose of STRO-002. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of positive anti-drug antibodies (ADAs) and changes over time. | Occurrence of positive anti-drug antibodies (ADAs) | From first dose of STRO-002 until 28 days after the last dose of STRO-002. |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are required to take folic acid-containing supplements, e.g., folate deficiency.
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| Name | Affiliation | Role |
|---|---|---|
| Kongli zhu | Tasly Pharmaceutical Group Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Cohort D(Phase IIa) | Experimental | Recurrent and/or progressive non-small-cell lung cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%). |
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| Cohort E(Phase IIa) | Experimental | Recurrent and/or progressive triple-negative breast cancer, confirmed by IHC testing with FolRα positive expression (TPS ≥ 25%). |
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DOR is defined as the time from the first documented response (CR or PR evaluated by RECIST v1.1) until the time of first documentation of disease progression by RECIST v1.1.
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Progression-free survival (PFS) | PFS is defined as a time from the first dose of STRO-002 to documented disease progression or death from any cause. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| FolRα and cancer antigen 125 (CA-125) levels measured in tumor tissue | A CA-125 response is defined as at least a 50% reduction in CA-125 levels from a pretreatment sample, and the response must be confirmed and maintained for at least 28 days. | From first dose of STRO-002 until 28 days after the last dose of STRO-002. |